(267 days)
No
The device description and performance studies focus on the mechanical and material properties of a bone anchor and suture, with no mention of AI or ML capabilities.
No
The device is described as an absorbable bone fixation screw used for the fixation of soft tissues to bone in orthopedic surgery. Its function is to hold tissues in place, not to treat or cure a disease or medical condition directly.
No
The device description indicates it is an absorbable bone fixation screw used to fix soft tissues to bone in orthopedic surgery, not to diagnose a condition.
No
The device description explicitly states it is an absorbable bone fixation screw and includes physical components like suture, driver shaft, and handle. It also details bench testing for material and mechanical performance, which are characteristic of hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Fix2Lock Function: The Fix2Lock is a surgical implant designed to fix soft tissue to bone within the body during orthopedic procedures. It is a mechanical device used for structural support and fixation, not for diagnostic testing of biological samples.
The description clearly states its intended use is for surgical procedures and its function is to fix soft tissues to bone. This falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, Siceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers. Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Product codes
MAI, MBI
Device Description
The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
▪ Material
- ASTM F2026: 2017 Standard specification for polyetheretherketone(PEEK) polymers for surgications
- ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
- Mechanical performance
- ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
- Sterilization, shelf-life and packaging for sterile product
- ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development validation and routine control of a sterilization and routine control of a sterilization process for medical devices
- ISO 11138-1:2006, Sterilization of health care products Biological indicators Part 1: General requirements - ISO 11138-2:2009, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11140-1:2014, Sterilization of health care products Chemical indicators Part 1: General requirements
- ISO 11737-1:2018 Sterilization of medical devices Microbiological methods- Part 1: Estimation of population of microorganisms on products
- ISO 11737-2:2009 Sterilization of medical devices Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
▪ Bacterial Endotoxin
- USP Bacterial Endotoxin Test
- USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
June 17, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Osteonic Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #303, 142, Gasan digital 1-ro Geumcheon-gu, Seoul 08507 Korea, Republic of
Re: K202806
Trade/Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MAI, MBI Dated: September 22, 2020 Received: September 23, 2020
Dear Sandlok Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202806
Device Name
Fix2Lock(Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
Indications for Use (Describe)
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, Siceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers. Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/2 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a blue diamond with lines inside. To the right of the shape, the word "OSTEONIC" is written in bold, dark blue letters. Below "OSTEONIC", the phrase "The Medical Explorer" is written in a smaller, lighter font.
The assigned 510(k) Number: K202806
01. Date of Submission: 2020.09.17
02. Applicant
Dakyung Ham OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho, 1206Ho, 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea, 102Ho, 103Ho, 24, Digital-ro 27-gil, Guro-gu, Seoul, Korea TEL: +82-2-6902-8456 FAX: +82-2-6902-8401 Email: dakham@osteonic.com
03. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org
04. Subject Device Identification
Trade Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Common Name: Bioabsorbable bone anchor Classification Name: fastener, fixation, non-biodegradable, soft tissue Classification Product Code: MAI Subsequent Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3030 Device Class: II
05. Indication for use
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
4
K202806 Page 2 of 4
Image /page/4/Picture/1 description: The image contains a logo for a company called OSTEONIC. The logo consists of a blue geometric shape resembling a stylized diamond or square with internal lines, positioned to the left of the company name. The text "OSTEONIC" is written in a bold, dark gray font, and below it, in a smaller, lighter font, is the tagline "The Medical Explorer".
06. Predicate devices
Predicate device 510(k) Number: K192032 Device Name: Fixone Biocomposite Small anchor Manufacturer: AJU Pharm Co., Ltd.
Reference device 510(k) Number: K192484 Device Name: Fixone Biocomposite anchor Manufacturer: AJU Pharm Co., Ltd.
510(k) Number: K181774 Device Name: Force Fiber ® Suture Manufacturer: Teleflex Medical Incorporated
510(k) Number: K172016 Device Name: Force Fiber Fusion™ Suture Manufacturer: Teleflex Medical Incorporated
07. Device Description
The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.
5
Image /page/5/Picture/1 description: The image shows the logo for Osteonic, a medical explorer company. The logo features a blue geometric shape resembling a stylized diamond or square with internal lines, positioned to the left of the company name. The text "OSTEONIC" is written in bold, dark font, and below it, in smaller, lighter font, is the tagline "The Medical Explorer."
08. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
▪ Material
- ASTM F2026: 2017 Standard specification for polyetheretherketone(PEEK) polymers for surgications
- ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
- Mechanical performance
- ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
- Sterilization, shelf-life and packaging for sterile product
- ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development validation and routine control of a sterilization and routine control of a sterilization process for medical devices
- ISO 11138-1:2006, Sterilization of health care products Biological indicators Part 1: General requirements - ISO 11138-2:2009, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11140-1:2014, Sterilization of health care products Chemical indicators Part 1: General requirements
- ISO 11737-1:2018 Sterilization of medical devices Microbiological methods- Part 1: Estimation of population of microorganisms on products
- ISO 11737-2:2009 Sterilization of medical devices Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
▪ Bacterial Endotoxin
- USP Bacterial Endotoxin Test
- USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests
09. Substantially Equivalent Conclusion
Table 1: Substantial Equivalence Comparison
| Product
Name | SUBJECT Device | PREDICATE Device
Fixone
Biocomposite
Small
anchor (K192032) | REFERENCE Device 1
Fixone
Biocomposite
anchor
(K192484) | Equivalence
Discussion |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product
code | MAI | MAI, MBI | MAI | Same |
| Regulatory
class | Class II | Class II | Class II | Same |
| Regulation
Number | 21 CFR 888.3030 | 21 CFR 888.3030 | 21 CFR 888.3030 | Same |
| Intended use | The Fix2Lock is intended use for
fixation of soft tissue to bone,
using suture, in the following
procedure:
shoulder, foot/ankle, knee,
hand/wrist and elbow.
Shoulder: Rotator Cuff Repair.
Bankart Repair, SLAP Lesion
Repair, Biceps Tenodesis,
Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular
Shift or Capsulolabral | The Fixone Biocomposite Small
Anchor are intended to be used
for suture (soft tissue) fixation to
bone in the foot, ankle, knee,
hand, wrist, elbow, shoulder, and
hip.
Shoulder: Rotator Cuff Repair,
Bankart Repair, SLAP Lesion
Repair, Biceps Tenodesis,
Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular
Shift or Capsulolabral | The Fixone Biocomposite
Anchors are intended for fixation
of suture (soft
tissue) to bone in the shoulder,
foot/ankle, knee and elbow in the
following procedures:
Shoulder: Rotator Cuff Repair,
Bankart
Repair, SLAP Lesion Repair,
Biceps
Tenodesis, Acromio-Clavicular
Separation | Similar |
| | Reconstruction
Foot/Ankle: Lateral Stabilization,
Medial Stabilization, Achilles
Tendon Repair, Metatarsal
Ligament Repair, Hallux Valgus
reconstruction, digital tendon
transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament
Repair, Lateral Collateral
Ligament Repair, Patellar Tendon
Repair, Posterior Oblique
Ligament Repair, Iliotibial Band
Tenodesis
Hand/Wrist: Scapholunate
Ligament Reconstruction, Carpal
Ligament Reconstruction,
Repair/Reconstruction of
collateral ligaments, Repair of
Flexor and Extensor Tendons at
the PIP, DIP, and MCP joints for
all digits, digital tendon transfers
Elbow: Biceps Tendon
Reattachment, Ulnar or Radial
Collateral Ligament
Reconstruction | Reconstruction Foot/Ankle:
Lateral Stabilization, Medial
Stabilization, Achilles Tendon
Repair, Metatarsal Ligament
Repair, Hallux Valgus
reconstruction, digital tendon
transfers, Midfoot reconstruction
Knee: Medial Collateral Ligament
Repair, Lateral Collateral
Ligament Repair, Patellar Tendon
Repair, Posterior Oblique
Ligament Repair, Iliotibial Band
Tenodesis
Hand/Wrist: Scapholunate
Ligament Reconstruction, Carpal
Ligament Reconstruction,
Repair/Reconstruction of
collateral ligaments, Repair of
Flexor and Extensor Tendons at
the PIP, DIP, and MCP joints for
all digits, digital tendon transfers
Elbow: Biceps Tendon
Reattachment, Ulnar or Radial
Collateral Ligament
Reconstruction
Hip: Capsular repair, Acetabular
Labral repair | Repair, Deltoid Repair, Capsular
Shift or
Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization,
Medial
Stabilization, Achilles Tendon
Repair;
Knee: Medial Collateral Ligament
Repair,
Lateral Collateral Ligament
Repair,
Posterior Oblique Ligament
Repair,
Iliotibial Band Tenodesis;
Elbow: Biceps Tendon
Reattachment,
Ulnar or Radial Collateral
Ligament
Reconstruction. | |
| Operating
Principles | Bone fixation screw that ties soft
tissues such as ligament, tendon,
and the articular capsules to bone. | Bone fixation screw that ties soft
tissues such as ligament, tendon,
and the articular capsules to bone. | Bone fixation screw that ties soft
tissues such as ligament, tendon,
and the articular capsules to bone. | Same |
| Material | Anchor:
-Biocomposite medial, lateral:
PLGA+ $\beta$ -TCP
-Biocombi self punching:
PLGA+ $\beta$ -TCP, PEEK
Suture: UHMWPE | Anchor:
PLGA+ $\beta$ -TCP
Suture: UHMWPE | Anchor:
PLGA+ $\beta$ -TCP
Suture: UHMWPE | Similar |
| Structure | This product consists of an
absorbable and/or non-absorbable
anchor, a non-absorbable suture
and driver shaft and handle. | This product consists of an
absorbable anchor, a non-
absorbable suture and driver shaft
and handle. | This product consists of an
absorbable anchor, a non-
absorbable suture and driver shaft
and handle. | Similar |
| Product
Size | Anchor diameter: Ø 2.6 to 6.5 mm
Anchor length: 10.0 to 20.8mm | Anchor diameter: Ø 3.0mm
Anchor length: 11.9mm | Anchor diameter: Ø 3.0 to 6.5 mm
Anchor length: 11.9 to 16.8mm | Similar |
| Sterilization | Sterile (EtO sterilization) | Sterile (EtO sterilization) | Sterile (EtO sterilization) | Same |
| Single Use/
Reuse | Single use | Single use | Single use | Same |
| Packaging | 1 EA / BOX | 1 EA / BOX | 1 EA / BOX | Same |
| Shelf -life | 5Years | 5Years | 5Years | Same |
6
Image /page/6/Picture/1 description: The image contains a logo with a blue geometric shape on the left and the word "OSTEONIC" in bold, dark gray letters on the right. Below "OSTEONIC" is the phrase "The Medical Explorer" in a smaller, lighter gray font. The geometric shape appears to be a stylized representation of a bone structure or a medical symbol.
Based on above, the subject device, Fix2Lock (Biocomposite lateral, Biocombi Self Punching), is determined to be Substantially Equivalent (SE) to the predicate devices, Fixone Biocomposite Small anchor (K192032) in respect of safety and effectiveness.